The five associations representing the dietary supplement industry have requested that FDA issue revised guidance on new dietary ingredient (NDI) notifications, with a specific focus on the information to be included to identify the new dietary ingredient.

The request, made by the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the Consumer Healthcare Products Association (CHPA), the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA), was made in the form of comments submitted by AHPA to FDA in April, and joined by CRN, CHPA, NPA and UNPA in separate submissions.

The groups noted that FDA’s rule on NDI notifications, as codified in 21 CFR 190.6, does not specifically state what information should be provided to the agency on the identity of the ingredient that is the subject of an NDI notification. Yet the most common objection communicated by FDA in its responses to NDI notifications is that the agency “is unable to establish the identity” of the dietary ingredient that is the subject of the notification.

Earlier comments submitted by each of the trade associations to FDA’s June 2011 draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” were generally critical. In June 2012, FDA informed the associations that the agency was planning to promulgate revised draft NDI guidance and would permit additional input from the industry on these topics.

Meanwhile, CRN recently provided its fifth substantive submission to FDA in response to the agency’s NDI Draft Guidance, this time through comments submitted by international law firm Steptoe & Johnson, LLP. This document specifically addresses when an ingredient is chemically altered such that it would require a separate NDI notification to FDA.

On behalf of CRN, the Steptoe & Johnson comments call on the agency to “take into account not only whether the chemical structure of the dietary ingredient has been changed, but also whether any change in structure is sufficiently significant to potentially cause dietary supplements containing the dietary ingredient to be unsafe for consumers.” In other words, FDA should examine not just the manufacturing process to determine what is chemically altered, but compare the starting and ending substances with an eye to whether those changes affected the safety of the end product.

The comments also urge FDA to consider the efficiency and effectiveness to be gained were the agency to focus on the chemical identity and safety of the dietary ingredient, as opposed to establishing an exhaustive list of manufacturing processes that do not chemically alter a dietary ingredient. Further, the comments suggest FDA look favorably to its own precedent in how it has previously approached the “chemically altered” definition as a model for NDIs, which focuses on whether the change in the method of production alters the chemical structure of the dietary ingredient in a way which has the potential to be significant for its safety. That standard of evaluation for chemical changes should be equally applicable under DSHEA as compared to other FDA-regulated food products.

Related Industry News

Holistic Primary Care, a practitioner-focused natural medicine publication, is anticipating its upcoming Practitioner Channel Forum to be held April 22-24, 2015 at the Coronado Island Marriott Resort. The conference will feature data f…

From March 16-20, 2015, as part of the 5th Annual AOAC INTERNATIONAL Mid-Year Meeting, AOAC and industry stakeholders will lead an effort to establish voluntary consensus standards for high-priority ingredients, with the goal of Official Methods. Und…

Ecuadorian Rainforest, LLC, Belleville, NJ, a wholesale nutraceuticals company, has now partnered with Powell May International, a Canadian food distributor, to help bring its nutraceutical ingredients to Canada.
Ecuadorian Rainforest has ch…

The Australia-based Soho Flordis International (SFI) is the recipient of the American Botanical Council (ABC) annual Varro E. Tyler Commercial Investment in Phytomedicinal Research Award. SFI is a global natural medicine company c…

A nationally representative survey showed that natural product use in the U.S. has shifted since 2007, with some products becoming more popular and some falling out of favor. Overall, natural products (dietary supplements other than vitamins and mine…

A group of six senators led by U.S. Sens. Sherrod Brown (D-OH) and Richard Blumenthal (D-CT) have petitioned FDA to ban the retail sale and marketing of pure caffeine powder.
“As long as this dangerous substance remains legal and readily ava…

Cultivating a strong immune system is a primary concern for supplement users, according to a survey from the Council for Responsible Nutrition (CRN). Results showed one quarter of the 150 million U.S. dietary supplement users take supplements for imm…

The Council for Responsible Nutrition Foundation (CRNF), Washington, D.C., has pledged additional grants now totaling more than $2.1 million to the National Advertising Division (NAD), a service of the advertising industry and the Council of Better B…

Partnering to produce slow-release omega-3 tablets from a variety of oils, including shrimp, krill, algal and fish oils, BlueOcean NutraSciences and CMAX Technologies have signed a joint venture agreement that combines BlueOcean's supply and mark…

Amin Talati, one of the foremost dietary supplement and pharmaceutical law practices under the direction of Rakesh Amin and Ashish Talati for the past 10 years, is now Amin Talati & Upadhye with the addition of its newest member, Shashank Upadhye…

Jana Hildreth, Synutra Pure’s director of technology and scientific affairs and a leading expert in chondroitin testing, updated the Pacific Southwest Section of AOAC International on official method development for chondroitin testing at its a…

With the quality and purity of dietary supplements recently being called into question, establishing a quality system is paramount to ensuring products are safe. Writing Standard Operating Procedures (SOPs) is the first step in creating this system f…

Nearly 17% of the U.S. population who take “immune health” dietary supplements have heard of the yeast fermentate ingredient EpiCor, according to a survey by Embria Health Sciences, Ankeny, IA, the makers of EpiCor and other proprietary f…

Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies. You can obtain detailed information about the use of cookies on our website by clicking on "More information”.